Artech Information System LLC
Scientist-IV
Artech Information System LLC, Raritan, New Jersey, us, 08869
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description
The Technical Operations Contractor is responsible for technical aspects of the Lifecycle Management structure and strategy for parenteral drug products including SIMPONI pre-filled syringes, STELARA pre-filled syringes, and Risperdal Consta Injection.The candidate will provide this technical support at U.S. based contract manufacturing sites such as Baxter Bloomington, IN and Alkermes, Wilmington, OH.The candidate will support technology transfers, implementation of continuous process verification programs, investigations, change control initiatives, and continuous process improvement programs.FUNCTIONAL KNOWLEDGE, SKILLS, AND ABILITIES:
Strong expertise with regard to pharmaceutical products & manufacturing processes with a focus on parenteral products.Good knowledge of regulatory requirements and GMP’s; understands the technical aspect of the lifecycle strategy of products.Applies the science-based risk approach and regulatory/GMP intelligence.Ability to create, maintain, and upgrade product technical knowledge and author documentation regarding these activities.Ability to monitor technical process and product performance across internal and external manufacturing sites and employ statistical methods to assess.Ability to participate in risk assessments with a quality and compliance perspective.PERSONAL & INTERPERSONAL SKILLS / LEADERSHIP SKILLS:
Ability to participate on cross-functional / cross-region project teams.Ability to manage complexity and change.Ability to interact at different levels of the organization (including Sr. Management).Ability to work under pressure and resolve conflicts.Ability to work independently under general direction, having a good sense of prioritization of assigned tasks and manage time accordingly.Ability to participate in a result-oriented project team.PERSONAL ATTITUDE & MINDSET:
Can-do mentality, agility & flexibility able to work with stretched goals and deadlines.Works with others towards the project team’s goals.Understands culture differences.Communicates, motivates, negotiates and is an assertive person having impact.Shows a high sense of responsibility regarding professional activities.Qualifications
DEGREE REQUIREMENT:
Minimum requirements: BS/BA with 3 to 5 years’ experience in pharmaceutical development or pharmaceutical manufacturing or related post-graduate academic experience/education.Additional Information
This is a time-sensitive and critical position; a quick response would be of great help.Contact Information:Sneha ShrivastavaTechnical Recruiter(973) 967 3348
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The Technical Operations Contractor is responsible for technical aspects of the Lifecycle Management structure and strategy for parenteral drug products including SIMPONI pre-filled syringes, STELARA pre-filled syringes, and Risperdal Consta Injection.The candidate will provide this technical support at U.S. based contract manufacturing sites such as Baxter Bloomington, IN and Alkermes, Wilmington, OH.The candidate will support technology transfers, implementation of continuous process verification programs, investigations, change control initiatives, and continuous process improvement programs.FUNCTIONAL KNOWLEDGE, SKILLS, AND ABILITIES:
Strong expertise with regard to pharmaceutical products & manufacturing processes with a focus on parenteral products.Good knowledge of regulatory requirements and GMP’s; understands the technical aspect of the lifecycle strategy of products.Applies the science-based risk approach and regulatory/GMP intelligence.Ability to create, maintain, and upgrade product technical knowledge and author documentation regarding these activities.Ability to monitor technical process and product performance across internal and external manufacturing sites and employ statistical methods to assess.Ability to participate in risk assessments with a quality and compliance perspective.PERSONAL & INTERPERSONAL SKILLS / LEADERSHIP SKILLS:
Ability to participate on cross-functional / cross-region project teams.Ability to manage complexity and change.Ability to interact at different levels of the organization (including Sr. Management).Ability to work under pressure and resolve conflicts.Ability to work independently under general direction, having a good sense of prioritization of assigned tasks and manage time accordingly.Ability to participate in a result-oriented project team.PERSONAL ATTITUDE & MINDSET:
Can-do mentality, agility & flexibility able to work with stretched goals and deadlines.Works with others towards the project team’s goals.Understands culture differences.Communicates, motivates, negotiates and is an assertive person having impact.Shows a high sense of responsibility regarding professional activities.Qualifications
DEGREE REQUIREMENT:
Minimum requirements: BS/BA with 3 to 5 years’ experience in pharmaceutical development or pharmaceutical manufacturing or related post-graduate academic experience/education.Additional Information
This is a time-sensitive and critical position; a quick response would be of great help.Contact Information:Sneha ShrivastavaTechnical Recruiter(973) 967 3348
#J-18808-Ljbffr